Catalog Number

-

Brand Name

Dyna-Link Elite

Version/Model Number

81-160-25

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K091301

Product Code

OVD

Product Code Name

Intervertebral Fusion Device With Integrated Fixation, Lumbar

Public Device Record Key

7da6eff4-17f2-4c10-8340-b511bd0c2687

Public Version Date

February 24, 2020

Public Version Number

4

DI Record Publish Date

May 24, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-